Boston Scientific recalled 32,695 ACCOLADE family pacemakers and related CRT-Ps after discovering software that could prevent entering Safety Mode when battery impedance is high. The recall is worldwide and classified as Class I with a high hazard level. Patients should stop using the devices and follow manufacturer instructions. Contact Boston Scientific or a healthcare provider for guidance.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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Pacemakers are implanted devices that regulate heart rhythm. The ACCOLADE family includes several models used for bradycardia support and CRT-P therapy.
A software issue could prevent initiation of Safety Mode in high impedance battery conditions, potentially compromising device safety functions.
This recall is not described as part of a broader industry pattern.
Patients may experience safety mode failures requiring medical oversight and possible device replacement; action is urgent due to high hazard.
Serial numbers and GTIN are listed in recall communications and FDA enforcement reports.
No specific timeline provided beyond recall issuance; patients should follow provider guidance.
Keep all recall communications, serial numbers, device ID, and clinician notes.
Brand: Boston Scientific. Product: ACCOLADE family pacemakers (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL) and VISIONIST and VALITUDE CRT-Ps. Model identifiers include GTIN 00802526558924 and serial numbers such as 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168. Distribution: Worldwide. Recall date: 2025-08-20. Status: Active.
No specific incident counts or injuries are provided in the documentation. The hazard is described but no injury data is included.
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